Clearance Summary
Aurie System received FDA 510(k) clearance under submission number DEN250023, sponsored by Cathbuddy, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-04-30.
- Submission: DEN250023
- Applicant / Sponsor: Cathbuddy, Inc.
- Clearance pathway: Direct
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5120
- Decision date: 2026-04-30
Classification & Regulation
This clearance is catalogued under FDA product code SHV and 21 CFR 876.5120, within the Gastroenterology, Urology review panel as a Class II device.